Modernizing Opioid Treatment Access Act

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Modernizing Opioid Treatment Access Act
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Long titleTo expand the take-home prescribing of methadone through pharmacies.
Announced inthe 118th United States Congress
Number of co-sponsors5
Legislative history

The Modernizing Opioid Treatment Access Act is a proposed United States congressional bill introduced in the 118th United States Congress. Introduced in response to the national opioid epidemic, the legislation would expand access to methadone, an approved medication for treating opioid use disorder (OUD). [1]

Contents

The bill would give pharmacies the ability to provide methadone to patients with OUD, which can currently only be accessed at methadone clinics. Additionally, the bill would allow approved healthcare providers to prescribe take-home doses for OUD patients. [2] [3]

Background

Federal law prohibit physicians from directly prescribing methadone for patients with opioid use disorder, and prevent pharmacies from dispensing the medication.

Classified as a schedule II substance, OUD patients are only permitted to access the medication at opioid treatment facilities (OTPs), known as methadone clinics. [4] Patients are generally required to visit clinics in-person to receive daily doses of methadone, and are usually prevented from receiving "take-home" doses. [5]  

Critics of these regulations note that while pharmacies are prohibited from dispensing methadone, they are permitted to dispense the same medication for pain. [6] However, opponents of relaxing regulations on methadone treatment for OUD argue that expanding access could lead to misuse of methadone. [7] [8]

Rules were enacted during the COVID-19 pandemic to increase OUD patients' ability to receive take-home doses of methadone. [9] [8] In 2022, the Substance Abuse and Mental Health Services Administration (SAMHSA) proposed to make expanded access permanent. [10]

Legislative history

On March 2, 2023, Senators Ed Markey (D-MA) and Rand Paul (R-KY) introduced the Senate version of the legislation, known as S.644. [11] Accompanying House legislation, known as H.R.1359, was introduced by Representatives Don Bacon (R-NE) and Donald Norcross (D-NJ). [12] As of July 25, 2023, the legislation has 24 co-sponsors in the House. [13] Representative David Trone, a Democrat from Maryland, has endorsed the legislation, arguing that current laws hinder patients' ability to receive medication. [14]

Support and opposition

The legislation is supported by the American Society of Addiction Medicine (ASAM), which represents addiction medicine professionals. [15] The legislation has received opposition from the American Association for the Treatment of Opioid Dependence (AAOTD), a trade group that represents the interests of methadone clinics. [16]

Related Research Articles

<span class="mw-page-title-main">Methadone</span> Opioid medication used for pain; also to treat opioid use disorder

Methadone, sold under the brand names Dolophine and Methadose among others, is a synthetic opioid agonist used for chronic pain and also for opioid use disorder. It is used to treat chronic pain, and it is also used to treat addiction to heroin or other opioids. Prescribed for daily use, the medicine relieves cravings and removes withdrawal symptoms. Withdrawal management using methadone can be accomplished in less than a month, or it may be done gradually over a longer period of time, or simply maintained for the rest of the patient’s life. While a single dose has a rapid effect, maximum effect can take up to five days of use. After long-term use, in people with normal liver function, effects last 8 to 36 hours. Methadone is usually taken by mouth and rarely by injection into a muscle or vein.

<span class="mw-page-title-main">Prescription drug</span> Medication legally requiring a medical prescription before it can be dispensed

A prescription drug is a pharmaceutical drug that is permitted to be dispensed only to those with a medical prescription. In contrast, over-the-counter drugs can be obtained without a prescription. The reason for this difference in substance control is the potential scope of misuse, from drug abuse to practicing medicine without a license and without sufficient education. Different jurisdictions have different definitions of what constitutes a prescription drug.

<span class="mw-page-title-main">Opioid use disorder</span> Medical condition

Opioid use disorder (OUD) is a substance use disorder characterized by cravings for opioids, continued use despite physical and/or psychological deterioration, increased tolerance with use, and withdrawal symptoms after discontinuing opioids. Opioid withdrawal symptoms include nausea, muscle aches, diarrhea, trouble sleeping, agitation, and a low mood. Addiction and dependence are important components of opioid use disorder.

<span class="mw-page-title-main">Buprenorphine</span> Opioid used to treat pain & opioid use disorder.

Buprenorphine, sold under the brand name Subutex among others, is an opioid used to treat opioid use disorder, acute pain, and chronic pain. It can be used under the tongue (sublingual), in the cheek (buccal), by injection, as a skin patch (transdermal), or as an implant. For opioid use disorder, it is typically started when withdrawal symptoms have begun and for the first two days of treatment under direct observation of a health-care provider.

A methadone clinic is a medical facility where medications for opioid use disorder (MOUD) are dispensed-—historically and most commonly methadone, although buprenorphine is also increasingly prescribed. Medically assisted drug therapy treatment is indicated in patients who are opioid-dependent or have a history of opioid dependence. Methadone is a schedule II (USA) opioid analgesic, that is also prescribed for pain management. It is a long-acting opioid that can delay the opioid withdrawal symptoms that patients experience from taking short-acting opioids, like heroin, and allow time for withdrawal management. In the United States, by law, patients must receive methadone under the supervision of a physician, and dispensed through an Opioid Treatment Program (OTP) certified by the Substance Abuse and Mental Health Services Administration and registered with the Drug Enforcement Administration.

The Drug Addiction Treatment Act of 2000, Title XXXV, Section 3502 of the Children's Health Act, permits physicians who meet certain qualifications to treat opioid addiction with Schedule III, IV, and V narcotic medications that have been specifically approved by the Food and Drug Administration for that indication.

Drug detoxification is variously the intervention in a case of physical dependence to a drug; the process and experience of a withdrawal syndrome; and any of various treatments for acute drug overdose.

<span class="mw-page-title-main">Heroin-assisted treatment</span> Prescribing of semi-synthetic heroin

Heroin-assisted treatment (HAT), or diamorphine assisted treatment, refers to a type of Medication-Assisted Treatment (MAT) where semi-synthetic heroin is prescribed to opiate addicts who do not benefit from, or cannot tolerate, treatment with one of the established drugs used in opiate replacement therapy such as methadone or buprenorphine. For this group of patients, heroin-assisted treatment has proven superior in improving their social and health situation. Heroin-assisted treatment is fully a part of the national health system in Switzerland, Germany, the Netherlands, Canada, and Denmark. Additional trials are being carried out in the United Kingdom, Norway, and Belgium.

An automated dispensing cabinet (ADC) is a computerized medicine cabinet for hospitals and healthcare settings. ADCs allow medications to be stored and dispensed near the point of care while controlling and tracking drug distribution. They also are called unit-based cabinets (UBCs), automated dispensing devices (ADDs), automated distribution cabinets or automated dispensing machines (ADMs).

In the United States, prescription monitoring programs (PMPs) or prescription drug monitoring programs (PDMPs) are state-run programs which collect and distribute data about the prescription and dispensation of federally controlled substances and, depending on state requirements, other potentially abusable prescription drugs. PMPs are meant to help prevent adverse drug-related events such as opioid overdoses, drug diversion, and substance abuse by decreasing the amount and/or frequency of opioid prescribing, and by identifying those patients who are obtaining prescriptions from multiple providers or those physicians overprescribing opioids.


Methadone maintenance treatment (MMT) utilizes methadone to treat dependence on heroin or other opioids, and is administered on an ongoing basis. Methadone is an opioid agonist that binds to the same receptors in the brain as heroin and other opioids. MMT is administered with the objective of relieving withdrawal symptoms. Higher doses of methadone may cause respiratory depression and/or euphoria in some patients. Methadone maintenance reduces the cravings for other opioids, and reduces the risk of fatal overdose from street drugs since the purity and strength of methadone is known, whereas substances obtained from the street vary significantly in strength and purity. Methadone maintenance has been termed "a first step toward social rehabilitation" because it increases the retention of patients in treatment, relieves them from the need to find, buy, and use multiple daily doses of street opioids, and offers a legal medical alternative.

<span class="mw-page-title-main">Buprenorphine/naloxone</span> Opioid treatment

Buprenorphine/naloxone, sold under the brand name Suboxone among others, is a fixed-dose combination medication that includes buprenorphine and naloxone. It is used to treat opioid use disorder, and reduces the mortality of opioid use disorder by 50%. It relieves cravings to use and withdrawal symptoms. Buprenorphine/­naloxone is available for use in two different forms, under the tongue or in the cheek.

<span class="mw-page-title-main">Opioid epidemic in the United States</span> Ongoing overuse of opioid medication in the US

In the United States, the opioid epidemic is an extensive ongoing overuse of opioid medications, both from medical prescriptions and illegal sources. The epidemic began in the United States in the late 1990s, according to the Centers for Disease Control and Prevention (CDC), when opioids were increasingly prescribed for pain management, resulting in a rise in overall opioid use throughout subsequent years. The great majority of Americans who use prescription opioids do not believe that they are misusing them.

The Illinois “Opioids-Covid-19-Naloxone” Resolution is legislation sponsored in the Illinois State Senate. The bill, numbered IL SR 1184, prompts the state of Illinois to examine the rise in opioid overdoses due to the COVID-19 pandemic. The bill also urges the state to improve and increase access to naloxone, an opioid overdose reversal drug.

The New York mandatory opioid antagonist prescription bill is legislation sponsored in the New York State Senate and Assembly. The Senate bill, numbered NY S. 5150-B, sponsored by state Senator Pete Harckham, will require prescribers to co-prescribe an opioid antagonist with the first opioid prescription of the year for certain high-risk patients to combat accidental overdoses.

The South Carolina opioid overdose prevention bill is legislation sponsored in the South Carolina state legislature. The bill, numbered SC H.B. 4711 and sponsored by state Representative Russell Fry, would require prescribers to offer a prescription for naloxone to patients at high risk of an opioid overdose.

Opioid agonist therapy (OAT) is a treatment in which prescribed opioid agonists are given to patients who live with Opioid use disorder (OUD). The benefits of this treatment include a more manageable withdrawal experience, cognitive improvement, and lower HIV transmission. The length of OAT varies from one individual to another based on their physiology, environmental surroundings, and quality of life.

<span class="mw-page-title-main">Prescription drug addiction</span> Medical condition

Prescription drug addiction is the chronic, repeated use of a prescription drug in ways other than prescribed for, including using someone else’s prescription. A prescription drug is a pharmaceutical drug that may not be dispensed without a legal medical prescription. Drugs in this category are supervised due to their potential for misuse and substance use disorder. The classes of medications most commonly abused are opioids, central nervous system (CNS) depressants and central nervous stimulants. In particular, prescription opioid is most commonly abused in the form of prescription analgesics.

TeleMAT is the combination of telehealth services and Medication-Assisted Treatment (MAT) with Buprenorphine for Opioid Use Disorder (OUD) patients.

In response to the surging opioid prescription rates by health care providers that contributed to the opioid epidemic in the United States, US states began passing legislation to stifle high-risk prescribing practices. These new laws fell primarily into one of the following four categories:

  1. Prescription Drug Monitoring Program (PDMP) enrollment laws: prescribers must enroll in their state's PDMP, an electronic database containing a record of all patients' controlled substance prescriptions
  2. PDMP query laws: prescribers must check the PDMP before prescribing an opioid
  3. Opioid prescribing cap laws: opioid prescriptions cannot exceed designated doses or durations
  4. Pill mill laws: pain clinics are closely regulated and monitored to minimize the prescription of opioids non-medically

References

  1. ↑ Ovalle, David (2023-03-05). "Experts, lawmakers push for expanded access to methadone to save lives". Washington Post. Retrieved 2023-07-25.
  2. ↑ Larson, Chris (2023-03-07). "Lawmakers Push for More At-Home Methadone Prescriptions". Behavioral Health Business. Retrieved 2023-07-07.
  3. ↑ Thakrar, Ashish (2023-04-10). "Opinion: Why are we denying people with opioid addiction the most effective treatment?". Los Angeles Times. Retrieved 2023-07-07. The bipartisan Modernizing Opioid Treatment Access bill, introduced in the Senate and the House last month, would do just that, dramatically expanding access.
  4. ↑ Facher, Lev (2022-08-18). "Biden administration has simple way to cut overdose deaths, experts say: expand methadone access". STAT. Retrieved 2023-07-07.
  5. ↑ Radil, Amy (2020-04-13). "Seattle addiction clinic welcomes new methadone guidelines in wake of coronavirus". KUOW. Retrieved 2023-07-07.
  6. ↑ Ovalle, David (2023-03-05). "As drug deaths soar, experts urge expanded access to methadone". Washington Post. Retrieved 2023-07-06. They note that methadone can already be prescribed by physicians and dispensed by pharmacies for chronic pain. With a fentanyl crisis raging, they argue, board-certified specialists should be able to write prescriptions to treat addiction.
  7. ↑ Nordstrom, Benjamin (2023-05-16). "Good intentions alone won't solve the country's opioid crisis". The Hill. Retrieved 2023-07-07.
  8. 1 2 Choi, Joseph (2023-07-12). "How the pandemic spurred a push to expand methadone access". The Hill. Retrieved 2023-07-26.
  9. ↑ "How COVID pandemic changed methadone treatment for addiction". AP News. 2021-08-12. Retrieved 2023-07-07.
  10. ↑ Mann, Brian (2022-12-17). "People addicted to opioids rarely get life-saving medications. That may change". NPR. Retrieved 2023-07-06. The rule-change proposed by the Biden administration would make those reforms permanent. It would also eliminate waiting periods for access to methadone and expand telehealth options even further.
  11. ↑ "S.644 – Modernizing Opioid Treatment Access Act". Congress.gov. Retrieved 2023-07-06.
  12. ↑ Fraser, Quanecia (2023-03-14). "'It will save lives': Rep. Don Bacon introduces bill to make opioid use disorder medication more accessible". KETV. Retrieved 2023-07-07.
  13. ↑ Redmond, Helen (2023-07-25). "Did ASAM Push to Limit Federal Methadone Reform Bill?". Filter. Retrieved 2023-07-29.
  14. ↑ McManus, Kevin (2023-03-14). "Two Bills To Deal With The Drug Problem Introduced This Week In Congress | WFMD-AM". WFMD. Retrieved 2023-07-07.
  15. ↑ Firth, Shannon (2023-05-18). "Addiction Doc Urges Lawmakers to Rethink Methadone Prescribing Restrictions". MedPageToday. Retrieved 2023-07-07.
  16. ↑ Redmond, Helen (2023-04-04). "Methadone Clinics Angry at Bad PR, But Not Afraid of SAMHSA". Filter. Retrieved 2023-07-07.
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